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U.S. Department of Health and Human Services

Final Rules and Final Orders: Food Additives and Color Additives
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Petition(s): CAP 3C0242

Listing of Color Additives for Coloring Contact Lenses; 1,4-Bis[4-(2-Methacryloxyethyl) Phenylamino]Anthraquinone Copolymers

Petitioner: Bausch & Lomb, Inc.
Docket number (legacy and/or former docket number(s)): (93C-0380)
Subject additive and intended use: amending the color additive regulations to provide for the safe use of the colored reaction product formed by copolymerizing 1,4-bis[4-(2-methacryloxyethyl)phenylamino]anthraquinone with 3-[tris(trimethylsiloxy)silyl]propyl vinyl carbamate (CAS Reg. No. 134072994) and N-vinyl pyrrolidone to form contact lenses
21 CFR* affected: 73.3106; 1,4-Bis[4-(2-methacryloxyethyl)phenylamino]anthraquinone copolymers
Substance(s)*, (CAS Registry® No.):
  • 1,4-bis(4-(2-methacryloxyethyl)phenylamino)anthraquinone (C.I. Reactive Blue 246), (121888-69-5)
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  • 3-(tris(trimethylsiloxy)silyl)propyl vinyl carbamate, (134072-99-4)
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    Federal Register publication history: Nov 3, 1993; 58 FR 58699; Notice
    Feb 27, 1995; 60 FR 10495; Final Rule; Effective date: Mar 30, 1995
    Jun 21, 1995; 60 FR 32264; Final Rule; confirmation of effective date; Effective date: Mar 30, 1995


     

    *Definitions

    • 21 CFR: Title 21 of the Code of Federal Regulations.
    • Substance: The name of the substance listed in the CFR.
    • CAS Registry® No.: Chemical Abstract Service (CAS) Registry Number® for the substance.
    • Petitions (see also Questions and Answers About the Petition Process)
      • FAP: Food Additive Petition
      • CAP: Color Additive Petition
      • GRP: GRAS Affirmation Petition (replaced by GRAS Notification Program in 1998)
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